A Portion-Controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS

Condition(s) targeted: Diabetes Mellitus

Intervention: Actos plus standard diet (Other); Actos plus structured diet (Other); Metformin plus standard diet (Other)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Pennington Biomedical Research Center

Official(s) and/or principal investigator(s):
George A Bray, MD, Principal Investigator, Affiliation: Pennington Center

We hypothesized that a portion controlled diet would prevent the weight gain associated with the use of a peroxisome profliferator-activated receptor-gamma (PPAR-g). This is a 4 months randomized clinical trial in type 2 diabetics who are treated with pioglitazone and a standard diet, pioglitazone and a portion-controlled diet and metformin with a standard diet.

Official title: A Portion-Controlled Diet Will Prevent Weight Gain in Diabetics Treated With ACTOS

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: glucose

Secondary outcome:

Change in lipids

blood pressure

Detailed description: A total of 60 male and female type 2 diabetic subjects will be recruited and randomized into 1 of 3 treatment groups for the 4 months long trial

1. ACTOS plus a standard diet

2. ACTOS plus a portion-controlled diet

3. Metformin plus a standard diet. The end-point of the trial is the change in body fat content from baseline to the end of the trial

Minimum age: 35 Years. Maximum age: 75 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Men and women age 35 to 75 who have type 2 diabetes mellitus

Exclusion Criteria:

- Individuals with co-existing other diseases

Pennington Center, Baton Rouge, Louisiana 70808, United States

Starting date: February 2003
Ending date: December 2008
Last updated: March 3, 2008